Markets in Clinical Trials for the Mega Rich?
October 27, 2014 2:13 PM Subscribe
If mega-rich people could buy places on clinical trials, would this help drive forward the development of new treatments that could benefit everyone?
The Problem: "For drug developers, there’s not much interest in rare cancers; for scientists, after the initial lab excitement of discovery has worn off, there’s little opportunity for glory left. Pushing new ideas into clinical testing is tedious, exhausting and takes time away from making other discoveries. Promising work that offers alternatives to the savage old therapies for such diseases is therefore difficult to fund and quickly forgotten."
A Solution?: There are over 12 million millionaires in the world – any one of these would want to buy a place on a trial if it might purchase relief or stave off death. Every one of them has people they love for whom they’d pay good money to get an extra chance. Why not set up a charitable or private body that would arrange these ‘sales’?
The Problem: "For drug developers, there’s not much interest in rare cancers; for scientists, after the initial lab excitement of discovery has worn off, there’s little opportunity for glory left. Pushing new ideas into clinical testing is tedious, exhausting and takes time away from making other discoveries. Promising work that offers alternatives to the savage old therapies for such diseases is therefore difficult to fund and quickly forgotten."
A Solution?: There are over 12 million millionaires in the world – any one of these would want to buy a place on a trial if it might purchase relief or stave off death. Every one of them has people they love for whom they’d pay good money to get an extra chance. Why not set up a charitable or private body that would arrange these ‘sales’?
"I wish we could live in a world where we were able to help people without having to focus on whether or not it was profitable to do so!"
"I know! Why don't we do nothing to address the roots of this problem, and instead, just figure out a way to game the system and make it profitable?"
I understand why this model is appealing to some people. Personally, it sends a cold shiver down my spine.
posted by showbiz_liz at 2:21 PM on October 27, 2014 [30 favorites]
"I know! Why don't we do nothing to address the roots of this problem, and instead, just figure out a way to game the system and make it profitable?"
I understand why this model is appealing to some people. Personally, it sends a cold shiver down my spine.
posted by showbiz_liz at 2:21 PM on October 27, 2014 [30 favorites]
See also Bruce Sterling's "Holy Fire".
posted by Inkslinger at 2:22 PM on October 27, 2014
posted by Inkslinger at 2:22 PM on October 27, 2014
"Lovey, The Dramaine trials the professor is running in his hut seem promising"
posted by clavdivs at 2:25 PM on October 27, 2014 [12 favorites]
posted by clavdivs at 2:25 PM on October 27, 2014 [12 favorites]
"I'm not a scientist or a physician; I have no medical training. "
Which is why you don't know what a biased sample is or why it's bad.
"I began with ethics, because I didn't know what that word meant"
Is this intended as satire, or does it merely function as satire?
posted by justsomebodythatyouusedtoknow at 2:27 PM on October 27, 2014 [19 favorites]
Which is why you don't know what a biased sample is or why it's bad.
"I began with ethics, because I didn't know what that word meant"
Is this intended as satire, or does it merely function as satire?
posted by justsomebodythatyouusedtoknow at 2:27 PM on October 27, 2014 [19 favorites]
I guess just ask for £2 million plus whatever incidental cost it is to buy and ship sugar pills back.
posted by ckape at 2:27 PM on October 27, 2014 [2 favorites]
posted by ckape at 2:27 PM on October 27, 2014 [2 favorites]
A millionaire isn't going to want to spend umpteen gazillion dollars for a potential cure for his wife, only to learn after she dies that she was assigned to the control group.
posted by Chocolate Pickle at 2:31 PM on October 27, 2014 [45 favorites]
posted by Chocolate Pickle at 2:31 PM on October 27, 2014 [45 favorites]
Use ailing billionaires in a clinical trial? Okay, as long as they're in the placebo group...
posted by oneswellfoop at 2:33 PM on October 27, 2014 [2 favorites]
posted by oneswellfoop at 2:33 PM on October 27, 2014 [2 favorites]
A millionaire isn't going to want to spend umpteen gazillion dollars for a potential cure for his wife, only to learn after she dies that she was assigned to the control groupThis specific concern is discussed at some length in the actual article with a number of specific suggestions that address it.
posted by Lame_username at 2:36 PM on October 27, 2014 [1 favorite]
Wow, a lot of very fast readers here! The treatment/control issue is discussed about halfway down:
posted by theodolite at 2:37 PM on October 27, 2014 [9 favorites]
“Then, until we can solve that limitation, the Dating Agency will not accept randomised controlled trials,” I grumbled.I'm not saying I'm convinced or anything, but there's more to clinical trials than the double-blind controlled experiments everyone is thinking of.
In medical parlance, there are typically three phases of trials a drug has to pass before it can be sold commercially. Phase I tests the tolerable dose range and safety in healthy volunteers or, in the case of serious diseases such as cancer, in sick patients. With a few exceptions, the doses used are too small to offer medical benefit. In phase II the research team tests efficacy, and uses the information from phase I to provide potentially therapeutic treatment at the optimal safe dose. This second phase of trialling can be divided into two parts: IIa, which is open to all suitable patients and has no placebo wing, and IIb, in which placebos and randomisation are introduced. Phase III tests whether the drug is better than the best already available – this is abominably expensive, involves hundreds of people and is not worth thinking about unless you’re a multibillionaire.
O’Connor’s objection therefore restricted the Dating Agency to brokering phase I or phase IIa trials. That’s not terrible. That’s almost all it was intended to do anyway: get promising preclinical research over the hurdle into early-stage clinical trials, because that comparatively small amount of money is way beyond the reach of ordinary university departments. Uppsala is a combined phase I/phase IIa trial.
posted by theodolite at 2:37 PM on October 27, 2014 [9 favorites]
TREAT THE RICH
posted by El Sabor Asiatico at 2:39 PM on October 27, 2014 [22 favorites]
posted by El Sabor Asiatico at 2:39 PM on October 27, 2014 [22 favorites]
We already have a successful method of encouraging drug creation for rare diseases. It's called the Orphan Drug Act.
Also, if you've got a terminal disease, you can often get FDA-sanctioned access to not-yet-approved drugs. You don't even have to be a millionaire.
posted by dephlogisticated at 2:46 PM on October 27, 2014 [4 favorites]
Also, if you've got a terminal disease, you can often get FDA-sanctioned access to not-yet-approved drugs. You don't even have to be a millionaire.
posted by dephlogisticated at 2:46 PM on October 27, 2014 [4 favorites]
Isn't this how more than one supervillian got started?
posted by JHarris at 2:46 PM on October 27, 2014 [14 favorites]
posted by JHarris at 2:46 PM on October 27, 2014 [14 favorites]
I shall strain a metaphor into a hernia: curiously, the resentment of the rich here is not only causing crabs to pull wealthier crabs back into the bucket, they're pulling in wealthy crabs who could have offered a lifeline to the rest of the crabs were they only allowed out.
This kills the crab.
posted by adipocere at 2:51 PM on October 27, 2014 [6 favorites]
This kills the crab.
posted by adipocere at 2:51 PM on October 27, 2014 [6 favorites]
You don't get rich by helping other people out, and you don't stay rich by spending your money on stuff, so my forecast: breezes.
posted by turbid dahlia at 2:59 PM on October 27, 2014
posted by turbid dahlia at 2:59 PM on October 27, 2014
theodolite makes some good points. This isn't just like, "We have a cure for your cancer but the stupid regulations demand we study it, give us money to cut in line for the cure!"
There are a lot of rare cancers, not all of them raise money with massive month long awareness campaigns because they impact incredibly small numbers of people each year. If we can both do good studies and inject in some money to snowball towards more studies, it kind of seems like a win-win to me. All of humankind can potentially benefit from the result of this research.
posted by Drinky Die at 3:38 PM on October 27, 2014 [6 favorites]
There are a lot of rare cancers, not all of them raise money with massive month long awareness campaigns because they impact incredibly small numbers of people each year. If we can both do good studies and inject in some money to snowball towards more studies, it kind of seems like a win-win to me. All of humankind can potentially benefit from the result of this research.
posted by Drinky Die at 3:38 PM on October 27, 2014 [6 favorites]
I've put forward in my class the ethical scenario: should rich people be allowed to buy first place for organ transplant if they pay for two people who can not afford it.
posted by dances_with_sneetches at 3:38 PM on October 27, 2014 [7 favorites]
posted by dances_with_sneetches at 3:38 PM on October 27, 2014 [7 favorites]
Beyond issues of class, buying spots in a double-blind study would be bad science. Such a study would self-select for people who are more likely to have characteristics that could potentially help them respond better to treatment (or differently).
Someone who is wealthy is likely to otherwise have lived with fewer stresses on their body up to the point of getting sick — and, further, they can proceed through a study with fewer stresses incurred from treatment (not just physical side effects, but life stresses, such as financial ones brought about from sudden and ongoing hospitalization) — so if wealthy people do well in the study, is it due to the therapeutic agent working better on a healthier, less-stressed patient, or is it due to the treatment working better regardless?
It is not really possible to control for this effect without randomization that would negate the point of bringing in "mega-rich" for their money, in the first place.
posted by a lungful of dragon at 3:42 PM on October 27, 2014 [3 favorites]
Someone who is wealthy is likely to otherwise have lived with fewer stresses on their body up to the point of getting sick — and, further, they can proceed through a study with fewer stresses incurred from treatment (not just physical side effects, but life stresses, such as financial ones brought about from sudden and ongoing hospitalization) — so if wealthy people do well in the study, is it due to the therapeutic agent working better on a healthier, less-stressed patient, or is it due to the treatment working better regardless?
It is not really possible to control for this effect without randomization that would negate the point of bringing in "mega-rich" for their money, in the first place.
posted by a lungful of dragon at 3:42 PM on October 27, 2014 [3 favorites]
I am all for this because this could possibly lead to a universe that's almost like Galaxy Express 999
posted by hellojed at 3:52 PM on October 27, 2014
posted by hellojed at 3:52 PM on October 27, 2014
I kinda get pissed when it seems like the only time a rich person or celebrity gets involved in a cause is when that person is affected by the affliction. Did Christopher Reeve give a shit about paralyzed people before he was? Nope. Did Michael J. Fox care about Parkinson's before he had it? Nope.
I know the reality is this isn't the case, that there are plenty of rich people out there fighting hard for illnesses they don't have, but sadly that's not the narrative we follow.
No one looks to Bill Gates and says, "Sorry about the malaria, dude."
This all said, find me a way to dump more cash into science and medicine and I am cool with it. Fuck, a 10% tax on nutritional supplements would work wonders.
posted by cjorgensen at 3:52 PM on October 27, 2014 [2 favorites]
I know the reality is this isn't the case, that there are plenty of rich people out there fighting hard for illnesses they don't have, but sadly that's not the narrative we follow.
No one looks to Bill Gates and says, "Sorry about the malaria, dude."
This all said, find me a way to dump more cash into science and medicine and I am cool with it. Fuck, a 10% tax on nutritional supplements would work wonders.
posted by cjorgensen at 3:52 PM on October 27, 2014 [2 favorites]
You guys understand that there's a mechanism through which we can use the money of rich people to pay for important social goods? It's called taxation.
posted by Horace Rumpole at 3:56 PM on October 27, 2014 [59 favorites]
posted by Horace Rumpole at 3:56 PM on October 27, 2014 [59 favorites]
If anything is bad from this idea, I think it's that you would be putting pressure on people with less money to come up with the money. My baby niece died of a rare brain cancer. My family is pretty well off, what would we do if some small possibility of a cure was being dangled there within financial achievability but outside of financial reasonability? Mortgage the family future on that hope? Back down and forever live what that choice?
Nah, we can't put people through this.
posted by Drinky Die at 4:01 PM on October 27, 2014 [17 favorites]
Nah, we can't put people through this.
posted by Drinky Die at 4:01 PM on October 27, 2014 [17 favorites]
My take? Start with Rawls's Second Principle Of Justice:
There will be equal opportunity for everyone to climb the economic and/or social ladder and that any social or economic inequalities that are allowed must be arranged so that they improve the access to Primary Goods for the Least Advantaged.
- substitute 'medical' for 'economic'.
posted by superelastic at 4:02 PM on October 27, 2014 [3 favorites]
There will be equal opportunity for everyone to climb the economic and/or social ladder and that any social or economic inequalities that are allowed must be arranged so that they improve the access to Primary Goods for the Least Advantaged.
- substitute 'medical' for 'economic'.
posted by superelastic at 4:02 PM on October 27, 2014 [3 favorites]
curiously, the resentment of the rich here is not only causing crabs to pull wealthier crabs back into the bucket, they're pulling in wealthy crabs who could have offered a lifeline to the rest of the crabs were they only allowed out.
That is a radically inappropriate use for that metaphor.
posted by Pope Guilty at 4:07 PM on October 27, 2014 [2 favorites]
That is a radically inappropriate use for that metaphor.
posted by Pope Guilty at 4:07 PM on October 27, 2014 [2 favorites]
If anything is bad from this idea, I think it's that you would be putting pressure on people with less money to come up with the money.
I'm very sorry about your niece passing. I would be all for bringing marginal taxation rates on the wealthy back to JFK-era levels, and using tax revenues to restore decades of increasingly lost federal funding to cancer and basic life sciences research programs, in order to try to make new therapies available without regard for financial considerations. That would help drive good science that benefits everyone.
posted by a lungful of dragon at 4:08 PM on October 27, 2014 [1 favorite]
I'm very sorry about your niece passing. I would be all for bringing marginal taxation rates on the wealthy back to JFK-era levels, and using tax revenues to restore decades of increasingly lost federal funding to cancer and basic life sciences research programs, in order to try to make new therapies available without regard for financial considerations. That would help drive good science that benefits everyone.
posted by a lungful of dragon at 4:08 PM on October 27, 2014 [1 favorite]
You guys understand that there's a mechanism through which we can use the money of rich people to pay for important social goods? It's called taxation.
There are hundreds, hell thousands of years of data on it so we already know it works!
posted by Ray Walston, Luck Dragon at 4:28 PM on October 27, 2014 [3 favorites]
There are hundreds, hell thousands of years of data on it so we already know it works!
posted by Ray Walston, Luck Dragon at 4:28 PM on October 27, 2014 [3 favorites]
How so, Pope Guilty?
Certainly, there's some wrinkles to be steamed out but the author has run it by quite a number of what you would call the appropriate parties, namely relevant lawyers and medical ethicists. As someone with something both funky and rare, I would be delighted to have even a moustache-twirling land baron interested in a feasible treatment or cure if I had a chance to go along for the ride.
Let's look at the payoff matrix for this: If it goes through, it benefits the rich (certainly, insofaras the drug might might work), some of the poor (who gain access to the treatment in question), and eventually everyone else as the trials go through.
However, if we seek to punish the rich and ill for being rich, we do so at the cost of these clinical trials. Crabs in a bucket, cutting your nose off to spite your face, tall poppy syndrome, take your pick.
posted by adipocere at 4:35 PM on October 27, 2014 [3 favorites]
Certainly, there's some wrinkles to be steamed out but the author has run it by quite a number of what you would call the appropriate parties, namely relevant lawyers and medical ethicists. As someone with something both funky and rare, I would be delighted to have even a moustache-twirling land baron interested in a feasible treatment or cure if I had a chance to go along for the ride.
Let's look at the payoff matrix for this: If it goes through, it benefits the rich (certainly, insofaras the drug might might work), some of the poor (who gain access to the treatment in question), and eventually everyone else as the trials go through.
However, if we seek to punish the rich and ill for being rich, we do so at the cost of these clinical trials. Crabs in a bucket, cutting your nose off to spite your face, tall poppy syndrome, take your pick.
posted by adipocere at 4:35 PM on October 27, 2014 [3 favorites]
Could someone who is reacting with disdain to this idea describe the problems with it? As someone who isn't involved in drug testing on any level, I'm not sure that I can think of the problems associated with letting certain people into drug tests if they pay enough money.
This seems like it could generally make drug tests larger and more widely available, since small pharma companies will have a bit more money at the testing stage. Unless the fear is that this is a bad thing (because many drugs don't work and/or have worse side effects that the 'cure' is worth), I'm not sure what there is to be outraged about here. Yes, the rich see a benefit (for drugs that work, at least), but it seems like a Pareto improvement over the current state of affairs.
posted by ayedub at 4:51 PM on October 27, 2014 [1 favorite]
This seems like it could generally make drug tests larger and more widely available, since small pharma companies will have a bit more money at the testing stage. Unless the fear is that this is a bad thing (because many drugs don't work and/or have worse side effects that the 'cure' is worth), I'm not sure what there is to be outraged about here. Yes, the rich see a benefit (for drugs that work, at least), but it seems like a Pareto improvement over the current state of affairs.
posted by ayedub at 4:51 PM on October 27, 2014 [1 favorite]
It's only "an improvement over the current state of affairs" because currently, in the US, drug discovery is inextricably tied to profit. This system would do nothing to address that problem- and it is a problem, because the system as it is prioritizes things like viagra over things like a cure for, say, ALS (thus the ice bucket shit).
posted by showbiz_liz at 4:55 PM on October 27, 2014 [1 favorite]
posted by showbiz_liz at 4:55 PM on October 27, 2014 [1 favorite]
It's only "an improvement over the current state of affairs" because currently, in the US, drug discovery is inextricably tied to profit. This system would do nothing to address that problem- and it is a problem, because the system as it is prioritizes things like viagra over things like a cure for, say, ALS (thus the ice bucket shit).
Okay, but even if I take this as true, and agree that the profit-motive is a problem, how is this change bad? From that point of view, this change still seems neutral. It isn't the needed overhaul, but it doesn't appear to be introducing new difficulties either.
posted by ayedub at 5:04 PM on October 27, 2014 [3 favorites]
Okay, but even if I take this as true, and agree that the profit-motive is a problem, how is this change bad? From that point of view, this change still seems neutral. It isn't the needed overhaul, but it doesn't appear to be introducing new difficulties either.
posted by ayedub at 5:04 PM on October 27, 2014 [3 favorites]
I work in clinical research and I'm basically not seeing anything all revolutionary or even really new proposed in this article. The rich can already "buy their way into" clinical trials. It's called having a disease, looking up a relevant study on clinicaltrials.gov and then flying out there and volunteering.
If the study team does not have funding to support additional enrollment, well, there's already dozens of private foundations that support clinical research. The David Koch Foundation (yes, one of those Koch's) spends a great deal of money on cancer research. The Adelson (yes, that Sheldon Adelson) Medical Research Foundation funds a number of research directions. I can pretty much be assured that if I see an AIDS, TB, or malaria trial occurring in the Global South that the Gates Foundation will be at least partially funding it.
The "Dating Agency" concept is interesting, but wealthy donors can already write checks to any of the non-profits that fund clinical research. The donor can then keep tabs on when the relevant clinical trial opens up (this does not happen overnight), and be first in line to volunteer. So this feels a bit like re-inventing the wheel.
And, as has already been pointed out, if you want a scientifically valid trial, you don't select potential subjects based on their bank account. You select them on the basis of what can be incredibly stringent eligibility/ineligibility criteria, even for Phase I/II trials. So basically his whole "fund a CT, get guaranteed access to the treatment" is borked right from the start.
This article also fucking reeks of therapeutic misconception. Phase I trials aren't even really interested in efficacy, they exist to make sure a particular compound won't kill you or destroy your liver, while also having some sort of biological activity. If we had the data that a new drug could cure pancreatic cancer, we wouldn't have to run phased clinical trials. We run clinical trials to get that data. Research =! Treatment.
The author of the article writes:
posted by Panjandrum at 5:06 PM on October 27, 2014 [34 favorites]
If the study team does not have funding to support additional enrollment, well, there's already dozens of private foundations that support clinical research. The David Koch Foundation (yes, one of those Koch's) spends a great deal of money on cancer research. The Adelson (yes, that Sheldon Adelson) Medical Research Foundation funds a number of research directions. I can pretty much be assured that if I see an AIDS, TB, or malaria trial occurring in the Global South that the Gates Foundation will be at least partially funding it.
The "Dating Agency" concept is interesting, but wealthy donors can already write checks to any of the non-profits that fund clinical research. The donor can then keep tabs on when the relevant clinical trial opens up (this does not happen overnight), and be first in line to volunteer. So this feels a bit like re-inventing the wheel.
And, as has already been pointed out, if you want a scientifically valid trial, you don't select potential subjects based on their bank account. You select them on the basis of what can be incredibly stringent eligibility/ineligibility criteria, even for Phase I/II trials. So basically his whole "fund a CT, get guaranteed access to the treatment" is borked right from the start.
This article also fucking reeks of therapeutic misconception. Phase I trials aren't even really interested in efficacy, they exist to make sure a particular compound won't kill you or destroy your liver, while also having some sort of biological activity. If we had the data that a new drug could cure pancreatic cancer, we wouldn't have to run phased clinical trials. We run clinical trials to get that data. Research =! Treatment.
The author of the article writes:
I’m not a scientist or a physician; I have no medical training. I’m a biographer and an illustrator, and until a couple of years ago I’d never heard of clinical trials.This is painfully obvious. Basically the only good idea this article has is that there should be more money in clinical research. The rest is just reinventing the wheel and proposing unsound research methods.
posted by Panjandrum at 5:06 PM on October 27, 2014 [34 favorites]
Such a study would self-select for people who are more likely to have characteristics that could potentially help them respond better to treatment (or differently).
Pardon my French, but so the fuck what? If they make a cure that works best for rich people and only moderately well for not-rich people, are we not still better off than we were before?
posted by corb at 5:07 PM on October 27, 2014 [2 favorites]
Pardon my French, but so the fuck what? If they make a cure that works best for rich people and only moderately well for not-rich people, are we not still better off than we were before?
posted by corb at 5:07 PM on October 27, 2014 [2 favorites]
Okay, but even if I take this as true, and agree that the profit-motive is a problem, how is this change bad? From that point of view, this change still seems neutral. It isn't the needed overhaul, but it doesn't appear to be introducing new difficulties either.
Currently it's "which drugs can we make the most money of in the mass market." This would be more like "which specific ailments do the 200 richest people in America have, we'll direct half of our R&D to those."
posted by showbiz_liz at 5:08 PM on October 27, 2014 [2 favorites]
Currently it's "which drugs can we make the most money of in the mass market." This would be more like "which specific ailments do the 200 richest people in America have, we'll direct half of our R&D to those."
posted by showbiz_liz at 5:08 PM on October 27, 2014 [2 favorites]
Pardon my French, but so the fuck what?
Clinical trials need to control for as many variables as possible in order to ensure that the tested compound is actually having the desired effect and any changes (positive or negative) in the subject are not the result of other factors.
I just pulled up a Phase I monoclonal antibody study to look at the inclusion criteria. While I can't give the specifics on account of confidentiality, I will sum up the inclusion/exclusion criteria and note that they are pretty standard, even more inclusive than some trials actually.
You need to have one of three specific cancers, which have already poorly responded to standard of care treatment; have been previously treated with the panel of some specific standard of care drugs being used to actually treat your cancer; have tolerated those drugs at those doses being used in the study without certain levels of toxicity; meet a minimum level of normal functioning in activities of daily life; and have liver, kidney, and bone marrow function within acceptable limits (no small feat for someone with progressing cancer).
Those are the inclusion criteria. You would be ineligible if your cancer is actually too far advanced; has CNS metastases; have a history of vascular events like pulmonary or deep vein thrombi; have previously had an investigational drug within a certain time frame; have been previously treated with drugs related to the study drug; have a history of allergic reactions to antibody drugs or any of the other drugs used in the study (including the antibiotic used in manufacturing the study drug); have a history of any other cancers besides the ones being studied; and meet a certain level of psychological health.
And this is all to participate in a Phase I trial, where the explicit goal is not to cure you, but to see if the study drug is safe to give to more people, at what dose, and to better understand how the drug actually works in the human body.
posted by Panjandrum at 5:28 PM on October 27, 2014 [12 favorites]
Clinical trials need to control for as many variables as possible in order to ensure that the tested compound is actually having the desired effect and any changes (positive or negative) in the subject are not the result of other factors.
I just pulled up a Phase I monoclonal antibody study to look at the inclusion criteria. While I can't give the specifics on account of confidentiality, I will sum up the inclusion/exclusion criteria and note that they are pretty standard, even more inclusive than some trials actually.
You need to have one of three specific cancers, which have already poorly responded to standard of care treatment; have been previously treated with the panel of some specific standard of care drugs being used to actually treat your cancer; have tolerated those drugs at those doses being used in the study without certain levels of toxicity; meet a minimum level of normal functioning in activities of daily life; and have liver, kidney, and bone marrow function within acceptable limits (no small feat for someone with progressing cancer).
Those are the inclusion criteria. You would be ineligible if your cancer is actually too far advanced; has CNS metastases; have a history of vascular events like pulmonary or deep vein thrombi; have previously had an investigational drug within a certain time frame; have been previously treated with drugs related to the study drug; have a history of allergic reactions to antibody drugs or any of the other drugs used in the study (including the antibiotic used in manufacturing the study drug); have a history of any other cancers besides the ones being studied; and meet a certain level of psychological health.
And this is all to participate in a Phase I trial, where the explicit goal is not to cure you, but to see if the study drug is safe to give to more people, at what dose, and to better understand how the drug actually works in the human body.
posted by Panjandrum at 5:28 PM on October 27, 2014 [12 favorites]
"I'm not a scientist or a physician; I have no medical training. "
So uh, why should we care what this doofus has to say? how is this not somewhere in the nexus of clickbait and trollbait as a total outrageous inflammatory uninformed opinion that seems tailor made to push buttons?
it's really like, dorm room philosophy 101 "iet's play devils advocate!" to me.
posted by emptythought at 5:35 PM on October 27, 2014 [5 favorites]
So uh, why should we care what this doofus has to say? how is this not somewhere in the nexus of clickbait and trollbait as a total outrageous inflammatory uninformed opinion that seems tailor made to push buttons?
it's really like, dorm room philosophy 101 "iet's play devils advocate!" to me.
posted by emptythought at 5:35 PM on October 27, 2014 [5 favorites]
It's only "an improvement over the current state of affairs" because currently, in the US, drug discovery is inextricably tied to profit. This system would do nothing to address that problem- and it is a problem, because the system as it is prioritizes things like viagra over things like a cure for, say, ALS (thus the ice bucket shit).
Viagra (sildenafil) under the brand name revatio is also used for pulmonary arterial hypertension. Punchline drug Botox likewise has various clinical uses unrelated to vanity.
Dis profit all you like, but absent profit the number of drugs would go down substantially. Which might be in some ways a good thing, but that's an argument for a different time.
posted by IndigoJones at 5:35 PM on October 27, 2014 [3 favorites]
Viagra (sildenafil) under the brand name revatio is also used for pulmonary arterial hypertension. Punchline drug Botox likewise has various clinical uses unrelated to vanity.
Dis profit all you like, but absent profit the number of drugs would go down substantially. Which might be in some ways a good thing, but that's an argument for a different time.
posted by IndigoJones at 5:35 PM on October 27, 2014 [3 favorites]
Clinical trials need to control for as many variables as possible in order to ensure that the tested compound is actually having the desired effect and any changes (positive or negative) in the subject are not the result of other factors.
Theoretically, couldn't the rich people who "bought their way onto a study" just be discarded as data points, if they aren't useful data points? I could see this being a problem if the study is choosing rich, unsuitable people instead of other suitable people, but if the study is choosing rich, unsuitable people in addition to the usual folks, this doesn't seem like an issue.
posted by ayedub at 5:36 PM on October 27, 2014 [1 favorite]
Theoretically, couldn't the rich people who "bought their way onto a study" just be discarded as data points, if they aren't useful data points? I could see this being a problem if the study is choosing rich, unsuitable people instead of other suitable people, but if the study is choosing rich, unsuitable people in addition to the usual folks, this doesn't seem like an issue.
posted by ayedub at 5:36 PM on October 27, 2014 [1 favorite]
If they make a cure that works best for rich people and only moderately well for not-rich people, are we not still better off than we were before?
Corb, in the United States, three times as much money is spent per person on health care administration than in socialist Canada. That's just administration, not even providing care.
Beyond administration inefficiencies, Forbes, not exactly a bastion of Marxist reporting, admits that the US ranks "dead last" in a ranking of health care cost, quality and outcomes among industrialized countries.
Capitalism, as practiced in the United States, has demonstrated it is a system that is incapable of efficient delivery of healthcare resources to the American public.
We are not better off than we were before. Indeed, Americans are demonstrably, measurably worse off for applying this economic model to such a basic human need.
We can do a bit better than wasteful and artificially-imposed scarcity, for which industrialized countries other than the United States have well-understood and working solutions: high marginal income taxation, social services, and single-payer healthcare (and well-funded public life sciences research).
posted by a lungful of dragon at 5:43 PM on October 27, 2014 [13 favorites]
Corb, in the United States, three times as much money is spent per person on health care administration than in socialist Canada. That's just administration, not even providing care.
Beyond administration inefficiencies, Forbes, not exactly a bastion of Marxist reporting, admits that the US ranks "dead last" in a ranking of health care cost, quality and outcomes among industrialized countries.
Capitalism, as practiced in the United States, has demonstrated it is a system that is incapable of efficient delivery of healthcare resources to the American public.
We are not better off than we were before. Indeed, Americans are demonstrably, measurably worse off for applying this economic model to such a basic human need.
We can do a bit better than wasteful and artificially-imposed scarcity, for which industrialized countries other than the United States have well-understood and working solutions: high marginal income taxation, social services, and single-payer healthcare (and well-funded public life sciences research).
posted by a lungful of dragon at 5:43 PM on October 27, 2014 [13 favorites]
If you are really so incredibly rich that donating $1 million is not a big deal, then I say, go for it. These treatments are unproven and potentially very dangerous, so it's not like you're really getting a leg up over the commoners.
Unfortunately there are a lot of people who could maybe-kinda-sorta scrape together $1 million, but it would financially destroy them and all their family and friends. I'd worry about those folks.
posted by miyabo at 5:47 PM on October 27, 2014 [5 favorites]
Unfortunately there are a lot of people who could maybe-kinda-sorta scrape together $1 million, but it would financially destroy them and all their family and friends. I'd worry about those folks.
posted by miyabo at 5:47 PM on October 27, 2014 [5 favorites]
curiously, the resentment of the rich here is not only causing crabs to pull wealthier crabs back into the bucket, they're pulling in wealthy crabs who could have offered a lifeline to the rest of the crabs were they only allowed out.
I don't think crabs believe in the trickle-down theory.
posted by fuse theorem at 5:53 PM on October 27, 2014
I don't think crabs believe in the trickle-down theory.
posted by fuse theorem at 5:53 PM on October 27, 2014
Theoretically, couldn't the rich people who "bought their way onto a study" just be discarded as data points
Compassionate use, where someone who fails to meet the necessary criteria to take part in a study, but nonetheless is given access to the study therapy, is a thing. Theoretically these Donor Warbucks could get access under that route. They would still need to meet basic clinical standards for their participation to not, you know, kill them. The ethics of compelling a health care provider to give you a treatment they have judged to have more risk than benefit based on the size of your bank account is an ethical nightmare the author does not seem to have really grappled with.
In the situation described by the author, however, we are necessarily talking about small scale drug manufacturing and small scale trials. So an individual outside the study parameters who is taking part in the trial is necessarily taking up not only drugs that are, by definition, limited in supply. They would also be taking up the time and resources of the study physicians and nurses. Not to mention that, again, providers are not under any ethical compulsion to treat their sponsors. If a trial is opened up for compassionate use, then basic medical ethics would demand enrollment be preferentially given to those with the greatest possibility of benefit, not the those who write the checks.
posted by Panjandrum at 5:58 PM on October 27, 2014 [6 favorites]
Compassionate use, where someone who fails to meet the necessary criteria to take part in a study, but nonetheless is given access to the study therapy, is a thing. Theoretically these Donor Warbucks could get access under that route. They would still need to meet basic clinical standards for their participation to not, you know, kill them. The ethics of compelling a health care provider to give you a treatment they have judged to have more risk than benefit based on the size of your bank account is an ethical nightmare the author does not seem to have really grappled with.
In the situation described by the author, however, we are necessarily talking about small scale drug manufacturing and small scale trials. So an individual outside the study parameters who is taking part in the trial is necessarily taking up not only drugs that are, by definition, limited in supply. They would also be taking up the time and resources of the study physicians and nurses. Not to mention that, again, providers are not under any ethical compulsion to treat their sponsors. If a trial is opened up for compassionate use, then basic medical ethics would demand enrollment be preferentially given to those with the greatest possibility of benefit, not the those who write the checks.
posted by Panjandrum at 5:58 PM on October 27, 2014 [6 favorites]
These treatments are unproven and potentially very dangerous
I cannot stress this enough. Careful preclinical testing and dose escalation means that very rarely do clinical trials end in dramatic certain death for participants, but trials can and do end because it turns out the compound under investigation was unavoidably toxic, or even just not better than placebo. Early Phase trials continually have new risks discovered, like the HIV vaccine that actually led to an increased risk of infection. Sometimes even drugs approved for certain indications can have new risks discovered as their use expands. Bevacizumab, just recently, was found to increase risk for necrotizing fasciitis.
Research is not treatment.
they're pulling in wealthy crabs who could have offered a lifeline to the rest of the crabs
Research is not treatment. And nobody is stopping those crabs from doing whatever the crustacean metaphor for writing checks to current medical research foundations, establishing their own foundations, or volunteering for clinical trials.
posted by Panjandrum at 6:10 PM on October 27, 2014 [9 favorites]
I cannot stress this enough. Careful preclinical testing and dose escalation means that very rarely do clinical trials end in dramatic certain death for participants, but trials can and do end because it turns out the compound under investigation was unavoidably toxic, or even just not better than placebo. Early Phase trials continually have new risks discovered, like the HIV vaccine that actually led to an increased risk of infection. Sometimes even drugs approved for certain indications can have new risks discovered as their use expands. Bevacizumab, just recently, was found to increase risk for necrotizing fasciitis.
Research is not treatment.
they're pulling in wealthy crabs who could have offered a lifeline to the rest of the crabs
Research is not treatment. And nobody is stopping those crabs from doing whatever the crustacean metaphor for writing checks to current medical research foundations, establishing their own foundations, or volunteering for clinical trials.
posted by Panjandrum at 6:10 PM on October 27, 2014 [9 favorites]
Unfortunately there are a lot of people who could maybe-kinda-sorta scrape together $1 million, but it would financially destroy them and all their family and friends. I'd worry about those folks.
There are already lots of woo-woo "therapies" that are not yet (never will be) clinically proven, which cost a huge amount of money, and which therefore operate outside the USA, Australia, or anywhere that regulates medicine responsibly. This proposal will probably direct more money to genuine medical research, but it will undoubtedly direct a whole lot more money to snake-oil vendors who will be able to set up "clinical trials" at home, rather than in China or Thailand or wherever. So while in theory this proposal sounds very sexy - it may help some people who are very sick while harming nobody healthy - in practice it makes it too easy for unscrupulous medical entrepreneurs to prey on the dying and desperate.
posted by Joe in Australia at 6:14 PM on October 27, 2014 [3 favorites]
There are already lots of woo-woo "therapies" that are not yet (never will be) clinically proven, which cost a huge amount of money, and which therefore operate outside the USA, Australia, or anywhere that regulates medicine responsibly. This proposal will probably direct more money to genuine medical research, but it will undoubtedly direct a whole lot more money to snake-oil vendors who will be able to set up "clinical trials" at home, rather than in China or Thailand or wherever. So while in theory this proposal sounds very sexy - it may help some people who are very sick while harming nobody healthy - in practice it makes it too easy for unscrupulous medical entrepreneurs to prey on the dying and desperate.
posted by Joe in Australia at 6:14 PM on October 27, 2014 [3 favorites]
This has blown my mind, in that, as mentioned by Horace above, we have the mechanism to do this already via taxation. That even considering that has us trying to jump through absurd hoops in the hope that the wealthy might do something useful with "their" wealth is...just beyond weird.
posted by maxwelton at 6:24 PM on October 27, 2014 [7 favorites]
posted by maxwelton at 6:24 PM on October 27, 2014 [7 favorites]
Leaving aside economic inequality in general and the systemic problems with health care access in our society and all of the OTHER issues we have in the world, what is wrong with this particular proposal for solving the very narrow problem it is hoping to solve?
If you let wealthy people fund trials directly, instead of indirectly through taxes or donations, who does that hurt exactly?
(Assuming they meet inclusion criteria for the study, their data are discarded if not needed, the supplies of the drug are not limited for other reasons, etc. In other words, assume all scientific and practical objections are met, including the important ones brought up by Panjandrum.)
*This is a genuine question. For those who would oppose it, why do you do so?*
posted by 3491again at 7:31 PM on October 27, 2014 [1 favorite]
If you let wealthy people fund trials directly, instead of indirectly through taxes or donations, who does that hurt exactly?
(Assuming they meet inclusion criteria for the study, their data are discarded if not needed, the supplies of the drug are not limited for other reasons, etc. In other words, assume all scientific and practical objections are met, including the important ones brought up by Panjandrum.)
*This is a genuine question. For those who would oppose it, why do you do so?*
posted by 3491again at 7:31 PM on October 27, 2014 [1 favorite]
I've put forward in my class the ethical scenario: should rich people be allowed to buy first place for organ transplant if they pay for two people who can not afford it.
Add a zero and you've got a deal.
posted by clarknova at 7:39 PM on October 27, 2014
Add a zero and you've got a deal.
posted by clarknova at 7:39 PM on October 27, 2014
I have absolutely no problems with this and I'm baffled why anyone would. You would rather a promising cure go unproven and unapproved -- potentially keeping it from ever reaching the rest of humanity -- than allow a wealthy person to have access to it in exchange for financing the trial? Cutting off your nose to spite your face.
If the data from the benefactor is not useful, throw out the data.
Should taxes fund study of every promising drug candidate? Absolutely. I'd love if that were true. I'd gladly remove this clearly inferior method of funding from contention the second that happens.
should rich people be allowed to buy first place for organ transplant if they pay for two people...
Completely different. Organ transplants require limited resources (organs) and have proven benefit. Additional drugs for these trials can be produced easily and have not proven their benefit nor safety. Anyone who volunteers to test a drug is doing a net service to humanity.
posted by the jam at 7:51 PM on October 27, 2014 [5 favorites]
If the data from the benefactor is not useful, throw out the data.
Should taxes fund study of every promising drug candidate? Absolutely. I'd love if that were true. I'd gladly remove this clearly inferior method of funding from contention the second that happens.
should rich people be allowed to buy first place for organ transplant if they pay for two people...
Completely different. Organ transplants require limited resources (organs) and have proven benefit. Additional drugs for these trials can be produced easily and have not proven their benefit nor safety. Anyone who volunteers to test a drug is doing a net service to humanity.
posted by the jam at 7:51 PM on October 27, 2014 [5 favorites]
Taxing the rich is nice, but it doesn't really deal with the problem under discussion: diseases too rare or too difficult to be a sensible investment.
posted by ThatFuzzyBastard at 8:12 PM on October 27, 2014 [1 favorite]
posted by ThatFuzzyBastard at 8:12 PM on October 27, 2014 [1 favorite]
There has literally never been a problem in medicine which hasn't been made much worse by letting rich people call the shots or get preference.
Boner pills maybe.
posted by Slarty Bartfast at 8:16 PM on October 27, 2014 [1 favorite]
Boner pills maybe.
posted by Slarty Bartfast at 8:16 PM on October 27, 2014 [1 favorite]
I'm totally down with performing medical experiments on the mega rich.
posted by lordrunningclam at 8:27 PM on October 27, 2014
posted by lordrunningclam at 8:27 PM on October 27, 2014
I kind of like the idea of getting millionaires to pay big bucks for poisonous drugs for rare afflictions that wouldn't have otherwise been tested. It's a nice combination of wealth redistribution and Darwinian mechanics rolled into one.
posted by kaibutsu at 8:37 PM on October 27, 2014
posted by kaibutsu at 8:37 PM on October 27, 2014
This is just trickle down research economics isn't it?
posted by srboisvert at 8:56 PM on October 27, 2014 [1 favorite]
posted by srboisvert at 8:56 PM on October 27, 2014 [1 favorite]
I think this is a terrible time to have this conversation, because we're in this space right now where people are kind of nervous--and where we've got some very promising new stuff in the way of Ebola vaccines and ZMapp and whatever, and we've got these stories about how ZMapp works in ways that could ultimately rewrite the history of west Africa in the impact it could have--it makes medical research seem so tedious and such a barrier in the way of all these possibilities. But that's not really how most pharmaceutical studies work, as has been noted. But right now we have this picture in the public consciousness that says miracles are so possible if we could just get more people these new and wonderful drugs.
What happens when some politician's wife dies just after everybody got their hopes up and suddenly he's lost his wife, he's out some huge chunk of money, and he decides that the medical profession is inherently untrustworthy even though they signed all kinds of waivers? A few high-profile disappointments--not just very sick people who succumb to their illnesses, but a drug that turns out to make that billionaire's teenager suicidal, say. Actress desperate to cure a disfiguring skin condition before it ruins her career funds the trial that produces the drug that leaves her permanently in a wheelchair. It's not that these things happen on a regular basis, but normally nobody's paid a million dollars for access to the thing that did it, before. Normally it's not people who run nations or huge media conglomerates. One such person dramatically losing faith in evidence-based medicine could translate very easily to a public health crisis.
We've already got a continuing vaccine problem that's been made worse by celebrity involvement. Imagine a Koch's grandkid is the trigger point. Imagine it's Benedict Cumberbatch. Someone with just enough reach--power or money or just rabid fans--gets impacted by a problem just severe enough to have a measurable impact on vaccination rates, or on legislation that impacts wider levels of health care funding. It's not just "bad things could happen to a rich person", it could really be very bad for everybody else.
posted by Sequence at 9:05 PM on October 27, 2014 [3 favorites]
What happens when some politician's wife dies just after everybody got their hopes up and suddenly he's lost his wife, he's out some huge chunk of money, and he decides that the medical profession is inherently untrustworthy even though they signed all kinds of waivers? A few high-profile disappointments--not just very sick people who succumb to their illnesses, but a drug that turns out to make that billionaire's teenager suicidal, say. Actress desperate to cure a disfiguring skin condition before it ruins her career funds the trial that produces the drug that leaves her permanently in a wheelchair. It's not that these things happen on a regular basis, but normally nobody's paid a million dollars for access to the thing that did it, before. Normally it's not people who run nations or huge media conglomerates. One such person dramatically losing faith in evidence-based medicine could translate very easily to a public health crisis.
We've already got a continuing vaccine problem that's been made worse by celebrity involvement. Imagine a Koch's grandkid is the trigger point. Imagine it's Benedict Cumberbatch. Someone with just enough reach--power or money or just rabid fans--gets impacted by a problem just severe enough to have a measurable impact on vaccination rates, or on legislation that impacts wider levels of health care funding. It's not just "bad things could happen to a rich person", it could really be very bad for everybody else.
posted by Sequence at 9:05 PM on October 27, 2014 [3 favorites]
This is just trickle down research economics isn't it?
Yes it is.
posted by futz at 9:17 PM on October 27, 2014
Yes it is.
posted by futz at 9:17 PM on October 27, 2014
You would rather a promising cure go unproven and unapproved -- potentially keeping it from ever reaching the rest of humanity -- than allow a wealthy person to have access to it in exchange for financing the trial? Cutting off your nose to spite your face.
I have some family friends whose father apparently had some sort of cancer - they didn't like talking about it, so I don't know exactly what it was. It was untreatable. They're not very rich, but he had some savings, and they borrowed some more from their kids, and they paid a huge amount so he could travel to China and get treated with magic woo juice while inhaling oxygen. It didn't work, of course.
The reason he travelled to China is that this sort of thing is illegal in Australia. The only medical treatments available in Australia are ones that are recognised, or ones administered within genuine medical trials. Medical treatment is highly regulated, and has been for many decades. We have learned that we need this because of the vulnerablity of patients and the voracity of hucksters and quacks. Sick people are often desperate; they are rarely able to evaluate the costs and beneifts of treatment in a disinterested way; they are highly vulnerable to abuse by people who claim to have some magical medical treatment that will stop the unstoppable, cure the incurable, or at least make the pain go away. Doctors, on the other hand, have too often been willing to make grandiose claims on the flimsiest of evidence, ruining people's lives and emptying their pockets. It isn't "wealthy" people who are the most susceptible to this: they can usually access better medical advice. It's people with moderate amounts of money, often retirees, who are persuaded to pour their little savings into the wallet of some travelling medical showman.
posted by Joe in Australia at 9:59 PM on October 27, 2014 [12 favorites]
I have some family friends whose father apparently had some sort of cancer - they didn't like talking about it, so I don't know exactly what it was. It was untreatable. They're not very rich, but he had some savings, and they borrowed some more from their kids, and they paid a huge amount so he could travel to China and get treated with magic woo juice while inhaling oxygen. It didn't work, of course.
The reason he travelled to China is that this sort of thing is illegal in Australia. The only medical treatments available in Australia are ones that are recognised, or ones administered within genuine medical trials. Medical treatment is highly regulated, and has been for many decades. We have learned that we need this because of the vulnerablity of patients and the voracity of hucksters and quacks. Sick people are often desperate; they are rarely able to evaluate the costs and beneifts of treatment in a disinterested way; they are highly vulnerable to abuse by people who claim to have some magical medical treatment that will stop the unstoppable, cure the incurable, or at least make the pain go away. Doctors, on the other hand, have too often been willing to make grandiose claims on the flimsiest of evidence, ruining people's lives and emptying their pockets. It isn't "wealthy" people who are the most susceptible to this: they can usually access better medical advice. It's people with moderate amounts of money, often retirees, who are persuaded to pour their little savings into the wallet of some travelling medical showman.
posted by Joe in Australia at 9:59 PM on October 27, 2014 [12 favorites]
I really feel like Panjandrum's comments neatly eviscerate the actual medical/research arguments in the article. And that we are really just dancing around the real problem, which is that we've let the rich rig the system so badly that they never pay their goddamn taxes but also get us to subsidize them every time they take a shit. They're bleeding us dry and a fancy workaround (which Panjandrum has demonstrated is actually unnecessary BS) won't fix it.
If we want more research, we need those at the top to pay more taxes. The rest of us sure don't have the scratch. And we shouldn't have to promise them magical cures for Aunt Sarah to get it, because that doesn't work anyway and because they already get the benefit of living in civilization and should pay to keep it going just like the rest of us do.
posted by emjaybee at 10:02 PM on October 27, 2014 [8 favorites]
If we want more research, we need those at the top to pay more taxes. The rest of us sure don't have the scratch. And we shouldn't have to promise them magical cures for Aunt Sarah to get it, because that doesn't work anyway and because they already get the benefit of living in civilization and should pay to keep it going just like the rest of us do.
posted by emjaybee at 10:02 PM on October 27, 2014 [8 favorites]
Unregulated private money's going to save medicine in America just like it's saved our politics.
posted by tonycpsu at 10:13 PM on October 27, 2014 [2 favorites]
posted by tonycpsu at 10:13 PM on October 27, 2014 [2 favorites]
It's only "an improvement over the current state of affairs" because currently, in the US, drug discovery is inextricably tied to profit. This system would do nothing to address that problem- and it is a problem, because the system as it is prioritizes things like viagra over things like a cure for, say, ALS (thus the ice bucket shit).
I don't really see the conflict here and, more to the point, I don't think there is a "the system as it is". There's a public system and private system, and you're only describing the latter.
If you want more research on drugs not tied to profit, there's a solution for that: increase taxes and throw that money at the NIH. That seems a lot simpler than...what? Overthrowing capitalism?
If people want to spend the money they have left over after taxes on pills for erectile dysfunction or anything else they like, what's the problem? It's not like more jobs for scientists would be a bad thing. And, sure, if taxes were high enough, there wouldn't be enough of that left-over money to fund private drug research but we're clearly a long way from that point right now.
posted by nicolas.bray at 10:20 PM on October 27, 2014 [1 favorite]
I don't really see the conflict here and, more to the point, I don't think there is a "the system as it is". There's a public system and private system, and you're only describing the latter.
If you want more research on drugs not tied to profit, there's a solution for that: increase taxes and throw that money at the NIH. That seems a lot simpler than...what? Overthrowing capitalism?
If people want to spend the money they have left over after taxes on pills for erectile dysfunction or anything else they like, what's the problem? It's not like more jobs for scientists would be a bad thing. And, sure, if taxes were high enough, there wouldn't be enough of that left-over money to fund private drug research but we're clearly a long way from that point right now.
posted by nicolas.bray at 10:20 PM on October 27, 2014 [1 favorite]
I'd also just like to point out that the total NIH budget amounts to only 1% of total US federal tax receipts.
You could double it very very easily. We're not really resource-constrained here.
posted by nicolas.bray at 10:25 PM on October 27, 2014 [3 favorites]
You could double it very very easily. We're not really resource-constrained here.
posted by nicolas.bray at 10:25 PM on October 27, 2014 [3 favorites]
"The system only prioritizes things like Viagra" is the new "The legal system is busted because some old lady sued McDonalds when she spilled coffee on herself!" It completely ignores the context.
Viagra wasn't developed because they were looking for a boner pill. It was an accident. They were looking for a treatment for pulmonary hypertension and angina. Which I assume passes people's moral test for allowable research. Except during the clinical trial people noticed they were getting super awesome mega boners. It turned out not to be a great a treatment for angina (although it does help with the PAH) so they moved forward with the new focus, which was super awesome mega boners.
Sure they made absolute bank with the boner thing. But it started as attempt to treat a rare disorder, pulmonary hypertension. Which is present in something like 15 people out of every million. Not thousand, million. The fact that it turned into a money printing bonanza was purely a happy accident.
So the development of Viagra shows the exact opposite of what people complaining about it are complaining about.
posted by Justinian at 10:28 PM on October 27, 2014 [14 favorites]
Viagra wasn't developed because they were looking for a boner pill. It was an accident. They were looking for a treatment for pulmonary hypertension and angina. Which I assume passes people's moral test for allowable research. Except during the clinical trial people noticed they were getting super awesome mega boners. It turned out not to be a great a treatment for angina (although it does help with the PAH) so they moved forward with the new focus, which was super awesome mega boners.
Sure they made absolute bank with the boner thing. But it started as attempt to treat a rare disorder, pulmonary hypertension. Which is present in something like 15 people out of every million. Not thousand, million. The fact that it turned into a money printing bonanza was purely a happy accident.
So the development of Viagra shows the exact opposite of what people complaining about it are complaining about.
posted by Justinian at 10:28 PM on October 27, 2014 [14 favorites]
You know what's great about this? Even if you take ethical issues completely off the table, it's merely an absolutely terrible and totally unworkable idea.
Knowing something about power law distribution I'm confident that the odds of any given millionaire having 2 million dollar is pretty low, never mind the the 100 million or so it takes to go from a laboratory sample suitable for a cell based bio-assay to clinical scale production with an analytical package that would get your clinical trial in the door anywhere besides Josef Mengele memorial hospital. Oh, and if you're doing this because you have a rare form of cancer and want your sorry ass saved, you probably don't want to cool your heels through the year or two of process and analytical development and reg tox screenings. For this plan to work (again, totally ignoring any issue of ethics, randomization or study profile) you'd have to have a bunch of millionaires who all knew they were going to get the same kind of rare cancer in about two or three years.
You'd be much better off convincing all your millionaire buddies to throw a few thousand at research and hope that your massive shotgun approach would result in the treatment you need when your doctor delivers the bad news.
posted by Kid Charlemagne at 11:56 PM on October 27, 2014 [7 favorites]
Knowing something about power law distribution I'm confident that the odds of any given millionaire having 2 million dollar is pretty low, never mind the the 100 million or so it takes to go from a laboratory sample suitable for a cell based bio-assay to clinical scale production with an analytical package that would get your clinical trial in the door anywhere besides Josef Mengele memorial hospital. Oh, and if you're doing this because you have a rare form of cancer and want your sorry ass saved, you probably don't want to cool your heels through the year or two of process and analytical development and reg tox screenings. For this plan to work (again, totally ignoring any issue of ethics, randomization or study profile) you'd have to have a bunch of millionaires who all knew they were going to get the same kind of rare cancer in about two or three years.
You'd be much better off convincing all your millionaire buddies to throw a few thousand at research and hope that your massive shotgun approach would result in the treatment you need when your doctor delivers the bad news.
posted by Kid Charlemagne at 11:56 PM on October 27, 2014 [7 favorites]
I've read the article through, and its not quite as crazy as some are suggesting here. I'm not convinced its super ethical, but its basically getting desperate rich people to gamble by helping get clinical trials to happen for drugs that have not even started testing. In a way, its a lottery for the rich and ill.
The problem being that most drugs fail, and even those drugs that do work usually aren't that much better than existing drugs. Also, because the money wouldn't usually be going to universities, it would be funding pharma companies and help them offset their costs of drug development. So increase their profit margins!
The idea that there is a wonder drug hiding out there which will vanish cancer is incorrect. If you look at the progress of the last few decades, you will see somewhat better drugs appear which cost more (because they are still under patent) and will give patients a few more years of life.
Also, we already throw quite a lot of money at cancer, and not in a fully principled way. One way that government can be better at spending research money is that it can make cold clinical decisions which desperate rich people cannot. Of course, seeing as we are unlikely to be raising taxes any time soon, I suppose we could prey on the wealthy for their money.
posted by Cannon Fodder at 3:25 AM on October 28, 2014 [3 favorites]
The problem being that most drugs fail, and even those drugs that do work usually aren't that much better than existing drugs. Also, because the money wouldn't usually be going to universities, it would be funding pharma companies and help them offset their costs of drug development. So increase their profit margins!
The idea that there is a wonder drug hiding out there which will vanish cancer is incorrect. If you look at the progress of the last few decades, you will see somewhat better drugs appear which cost more (because they are still under patent) and will give patients a few more years of life.
Also, we already throw quite a lot of money at cancer, and not in a fully principled way. One way that government can be better at spending research money is that it can make cold clinical decisions which desperate rich people cannot. Of course, seeing as we are unlikely to be raising taxes any time soon, I suppose we could prey on the wealthy for their money.
posted by Cannon Fodder at 3:25 AM on October 28, 2014 [3 favorites]
The article is much more thoughtful than it's being given credit for in this thread. I still have some significant reservations but before you comment it's worth reading through everything so you can at least respond to the article's arguments directly. (Also, congrats to this article for sending me back to my Good Clinical Practices training reference material - I usually avoid it like the plague because it's the same damn training we do every year.)
I do think Pandjandrum, Sequence, and Justinian, among others here, made some good points.
posted by Wretch729 at 6:55 AM on October 28, 2014 [1 favorite]
I do think Pandjandrum, Sequence, and Justinian, among others here, made some good points.
posted by Wretch729 at 6:55 AM on October 28, 2014 [1 favorite]
There has literally never been a problem in medicine which hasn't been made much worse by letting rich people call the shots or get preference.
I understand that hatred is an emotion that must find an outlet in most people and the rich are the safest target, esp. in the blue, but you can't make blanket statements like that without a little elaboration. Counter-arguments just off the top of my head:
The uber rich Bill Gates funded Gates foundation and malaria - better or worse? Various cures and treatment from big pharma - better or worse? The BMW driving cardiac surgeon who regularly performs double by-pass - better or worse?
As to getting preference, on the macro scale at least, preference comes to whomever has the better PR, the better organization and is the most noisy. Thus breast cancer more NCI money than lung and prostate cancer combine, even though the latter two are more common. (Perhaps other organizations take up the slack, I don't know, but the NCI doesn't seem to take that into account when doling out money.) Or consider Michael J. Fox bringing a lot more money to Parkinson's research than had he not become stricken himself- is that a rich person getting preference, and if so, is that a good thing or bad thing?
posted by IndigoJones at 10:17 AM on October 28, 2014 [1 favorite]
I understand that hatred is an emotion that must find an outlet in most people and the rich are the safest target, esp. in the blue, but you can't make blanket statements like that without a little elaboration. Counter-arguments just off the top of my head:
The uber rich Bill Gates funded Gates foundation and malaria - better or worse? Various cures and treatment from big pharma - better or worse? The BMW driving cardiac surgeon who regularly performs double by-pass - better or worse?
As to getting preference, on the macro scale at least, preference comes to whomever has the better PR, the better organization and is the most noisy. Thus breast cancer more NCI money than lung and prostate cancer combine, even though the latter two are more common. (Perhaps other organizations take up the slack, I don't know, but the NCI doesn't seem to take that into account when doling out money.) Or consider Michael J. Fox bringing a lot more money to Parkinson's research than had he not become stricken himself- is that a rich person getting preference, and if so, is that a good thing or bad thing?
posted by IndigoJones at 10:17 AM on October 28, 2014 [1 favorite]
Leaving aside economic inequality in general and the systemic problems with health care access in our society and all of the OTHER issues we have in the world, what is wrong with this particular proposal for solving the very narrow problem it is hoping to solve?
If you ignore reasons it's a bad idea, then it isn't bad I guess.
Health is a public good, and I think a lot of people here feel that taxation is how you're supposed to fund public goods. If you work instead through private donors, you get a system that's optimized towards satisfying the wishes of private donors. I worry, and I don't think this is irrational, that you'd get a shifting Overton Window in which people and doctors begin to think that it's only natural that the rich get priority in medicine since they're the ones paying for it (you know, in cash not sweat). The Just-World hypothesis is a very real factor in these sorts of situations.
It's worse than that though, because it normalizes and encourages dependency on private donors, solidifying a suboptimal Nash Equilibrium in which the objectively better-for-the-public public option has to overcome sunk costs and lobbying from the economic systems of the wealthy ("Why pay more in taxes when that's an already solved problem!? We can simply depend on the rich to fund our health, if they so choose!").
Again, health is a public good. The causes, spread, and results of disease are public problems. Medicine should be optimized towards serving the public. Sure, that's not always the case... but it should always be our model.
posted by tychotesla at 11:09 AM on October 28, 2014 [3 favorites]
If you ignore reasons it's a bad idea, then it isn't bad I guess.
Health is a public good, and I think a lot of people here feel that taxation is how you're supposed to fund public goods. If you work instead through private donors, you get a system that's optimized towards satisfying the wishes of private donors. I worry, and I don't think this is irrational, that you'd get a shifting Overton Window in which people and doctors begin to think that it's only natural that the rich get priority in medicine since they're the ones paying for it (you know, in cash not sweat). The Just-World hypothesis is a very real factor in these sorts of situations.
It's worse than that though, because it normalizes and encourages dependency on private donors, solidifying a suboptimal Nash Equilibrium in which the objectively better-for-the-public public option has to overcome sunk costs and lobbying from the economic systems of the wealthy ("Why pay more in taxes when that's an already solved problem!? We can simply depend on the rich to fund our health, if they so choose!").
Again, health is a public good. The causes, spread, and results of disease are public problems. Medicine should be optimized towards serving the public. Sure, that's not always the case... but it should always be our model.
posted by tychotesla at 11:09 AM on October 28, 2014 [3 favorites]
Regulatory toxicologist chiming in.
The most essential broken part of this proposal is its absolute lack of awareness of how drugs are developed before reaching first-in-man trials. This part of the process doesn't work in any systematic way, and drug candidates very, very rarely make it out of preclinical testing (e.g. development in animal models that ostensibly predict human efficacy and safety, despite excelling at the opposite). This is thoroughly acknowledged in the tox field, which is the principal component of drug development (field-wise); regulators are struggling with its implications, but there it is.
I’m not a scientist or a physician; I have no medical training. I’m a biographer and an illustrator, and until a couple of years ago I’d never heard of clinical trials.
That would explain it, then. A much better proposal would be for the research engines of the world to better develop predictive toxicology tools that can guide drug development in a human relevant direction. This is A Big Deal, much bigger than orphan drugs, and has been outlined since 2007 (in the US) in the NRC's Toxicity Testing in the 21st Century: A Vision and A Strategy. EPA and other US federal agencies have been working on the policy side of this for years now--the so-called Tox21 initiative(s)--but FDA is only grudgingly getting there. It's a much bigger focus in the EU already.
posted by late afternoon dreaming hotel at 12:52 PM on October 28, 2014 [4 favorites]
The most essential broken part of this proposal is its absolute lack of awareness of how drugs are developed before reaching first-in-man trials. This part of the process doesn't work in any systematic way, and drug candidates very, very rarely make it out of preclinical testing (e.g. development in animal models that ostensibly predict human efficacy and safety, despite excelling at the opposite). This is thoroughly acknowledged in the tox field, which is the principal component of drug development (field-wise); regulators are struggling with its implications, but there it is.
I’m not a scientist or a physician; I have no medical training. I’m a biographer and an illustrator, and until a couple of years ago I’d never heard of clinical trials.
That would explain it, then. A much better proposal would be for the research engines of the world to better develop predictive toxicology tools that can guide drug development in a human relevant direction. This is A Big Deal, much bigger than orphan drugs, and has been outlined since 2007 (in the US) in the NRC's Toxicity Testing in the 21st Century: A Vision and A Strategy. EPA and other US federal agencies have been working on the policy side of this for years now--the so-called Tox21 initiative(s)--but FDA is only grudgingly getting there. It's a much bigger focus in the EU already.
posted by late afternoon dreaming hotel at 12:52 PM on October 28, 2014 [4 favorites]
a lungful of dragon: Beyond issues of class, buying spots in a double-blind study would be bad science.And not what we're discussing. Please RTFA.
posted by IAmBroom at 1:24 PM on October 28, 2014
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This is a Really Bad Idea, for a variety of reasons.
posted by NoxAeternum at 2:19 PM on October 27, 2014 [17 favorites]